Biogen Idec Inc.’s BIIB shares hit a new 52-week high of $475.98 on Mar 20 after the company reported positive pre-specified interim results from a phase Ib study (PRIME) on its anti-amyloid beta antibody, aducanumab (BIIB037). Biogen is evaluating aducanumab for the treatment of Alzheimer’s disease (AD).
The data was presented at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders. Overall, the stock has gained 9.8% on the news.
The randomized, double-blind, placebo-controlled, multiple-dose phase Ib study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of aducanumab in patients suffering from prodromal or mild AD. The company reported 54-week data at the 1 mg/kg, 3 mg/kg and 10 mg/kg doses arms and a 6 mg/kg dose through week 30.
Interim results revealed that when treated with aducanumab, patients demonstrated a statistically significant dose- and time-dependent reduction (at 3 and 10mg/kg doses) of amyloid plaque in the brain when observed after 54 weeks of treatment. However, there were some side effects called amyloid-related imaging abnormalities.
Based on the promising phase Ib study results, Biogen intends to move the candidate into phase III later this year.
We are encouraged by the results from the early-stage study. As per data provided by the World Health Organization, in 2010, an estimated 25 million reported to be suffering from AD across the world.
The AD market offers huge commercial potential and a successfully developed product could bring in billions of dollars in sales. However, we note that the successful development of therapies for the treatment of AD is challenging and several companies including Eli Lilly and Co. LLY have faced significant setbacks.
Currently, Eli Lilly is working on developing treatments for AD. While solanezumab is in a phase III study, AZD3293, being jointly developed with AstraZeneca AZN, is in a phase II/III study.
Biogen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Acorda Therapeutics, Inc. ACOR carrying a Zacks Rank #1 (Strong Buy).